REWARD MI study

1. REAL WORLD COMPARISON OF MGUARD
STENT VERSUS BARE METAL STENT FOR ST
ELEVATION MYOCARDIAL INFARCTION.
THE REWARD-MI STUDY
A. Fernandez Cisnal(1), B. Cid-Alvarez (2), B. Alvarez-Alvarez (2), JM. Cubero-Gomez (1), R. Ocaranza-
Sanchez (2), D. Lopez-Otero(2), P. Souto-Castro (2), R. Trillo-Nouche (2), JR. Gonzalez-Juanatey (2)
1University Hospital of Virgen del Rocio, Seville, Spain 2 University Hospital of Santiago de Compostela, Santiago de
Compostela, Spain

2. BACKGROUND
2
The MGuard Stent (MGS) was designed to prevent distal
embolisation of thrombus in STEMI patients.
1980 Stone et al. JACC Vol. 60, No. 19, 2012
It has been MGuard in shown STEMI to improve microcirculation November in 6, 2012:ST-1975–elevation
84
myocardial infarction.
AnTgaibolgera3phicAMngeioagsurarepshiPcoMste-PasCuIres Post-PCI
MGuard Stent
Control Stent
(n ! 217)
(n ! 216) p Value
Device success* 208 (95.9) 214 (99.1) 0.03
Lesion success† 217 (100.0) 215 (99.5) 0.50
Angiographic success‡ 199 (91.7) 178 (82.4) 0.004
Reference vessel diameter, mm§ 3.20 (2.90–3.46) 3.16 (2.91–3.46) 0.99
Minimal luminal diameter, mm§
In-stent 2.99 (2.73–3.25) 2.99 (2.69–3.31) 0.91
In-lesion 2.64 (2.40–2.96) 2.64 (2.36–2.95) 0.82
Diameter stenosis, %§
In-stent 6.9 (4.2–10.5) 6.4 (3.9–10.3) 0.56
In-lesion 15.3 (9.6–21.2) 15.4 (10.8–21.2) 0.66
TIMI flow grade§
0/1 4 1.8) 12 5.6) 0.01
2 14 6.5) 25 11.6) 0.06
3 199 91.7) 179 82.9) 0.006
Corrected TIMI frame count§ 17.0 (12.0–23.0) 18.0 (13.0–22.0) 0.23
Myocardial blush grade§
0/1 35 16.1) 32 14.8) 0.71
2 21 (9.7) 28/215 (13.0) 0.27
3 161 74.2) 155/215 72.1) 0.62
2/3 182 83.9) 183 84.7) 0.81
IPTE§ 47 (21.7) 48/215 (22.3) 0.87
1980 Stone et al. JACC Vol. 60, No. 19, 2012
MGuard in STEMI November 6, 2012:1975–84
AnTgaibolgera3phicAMngeioagsurarepshiPcoMste-PasCuIres Post-PCI
MGuard Stent
(n ! 217)
Control Stent
(n ! 216) p Value
Device success* 208 (95.9) 214 (99.1) 0.03
Lesion success† 217 (100.0) 215 (99.5) 0.50
Angiographic success‡ 199 (91.7) 178 (82.4) 0.004
Reference vessel diameter, mm§ 3.20 (2.90–3.46) 3.16 (2.91–3.46) 0.99
Minimal luminal diameter, mm§
In-stent 2.99 (2.73–3.25) 2.99 (2.69–3.31) 0.91
In-lesion 2.64 (2.40–2.96) 2.64 (2.36–2.95) 0.82
Diameter stenosis, %§
In-stent 6.9 (4.2–10.5) 6.4 (3.9–10.3) 0.56
In-lesion 15.3 (9.6–21.2) 15.4 (10.8–21.2) 0.66
TIMI flow grade§
0/1 4 (1.8) 12 (5.6) 0.01
Stone et al. JACC Vol. 60, No. 19, 2012:1975–84. MGuard in STEMI

3. 3
BACKGROUND
There are no real world data comparing it with the bare
metal stent (BMS).
The aim of this study is to determine the
efficacy and safety of the MGS in STEMI in the
real world compared to the BMS.

4. 4
METHODS
All STEMI patients undergoing primary angioplasty
between July 2011 and January 2013 were included in the
study.
Exclusion criteria:
Cardiogenic shock (Killip IV).
DES implantation.

5. 5
METHODS
262 patients were included from a single centre.
Two groups of 79 patients were established after
propensity score matching (PSM).
MGS (79) BMS (79) p
Age (years) 59[51,69] 62[56,76] 0,141
Gender (male%) 86,1 (68) 87,1 (74) 0,513
Hypertension (%) 46,8 (37) 40,5 (32) 0,423
Diabetes mellitus (%) 20,3 (16) 12,7 (10) 0,198
Hypercholesterolemia (%) 50,6 (40) 45,6 (36) 0,524
Smoking (%) 62,0 (49) 53,2 (42) 0,260
Infarct related artery RCA(%) 55,7 (44) 64,6 (51) 0,213
Basal TIMI flow (0 %) 88,6 (70) 86,1(68) 0,566
Post-stent TIMI flow 3 (%) 97,5(77) 94,9(75) 0,339
Thrombectomy 83,5 (66) 82,3(65) 0,833
Total stent lenght (mm) 23,13±13,65 23,65±11,16 0,794
Maximal stent diameter (mm) 3,30±0,38 3,34±0,47 0,610
Similar in terms of baseline and periprocedural variables.

6. 6
RESULTS
The mean follow-up was 321 ± 12.94 days. T
Mortality
MACE
12,7%
7,6%
7,6%
20,3%
0% 5,5% 11% 16,5% 22%
There was no difference:
Mortality: 7.6% in both groups.
MACE: 20.3% vs. 12.7%, P = 0.198
CV mortality or non-fatal MI: 6.3% in both groups.

7. 7
RESULTS
Target lesion revascularisation (TLR) was significantly
higher in the MGS group:
11.4% vs. 1.3% P < 0.01
RR 10.02 [1.23 to 81.16]
TLR
1,3%
11,4%
0% 3% 6% 9% 12%

8. 8
RESULTS
Unmatched Matched
MGS (n = 92) BMS (n = 170) P MGS (n = 79) BMS (n = 79) P
MACE 18.5% (17) 14.1% (24) 0.51 20.3% (16) 12.7% (10) 0.20
All-cause mortality 6.5% (6) 8.8% (15) 0.35 7.6% (6) 7.6% (6) 1.00
CV mortality and non-fatal MI 7.6% (7) 7.1% (12) 0.87 6.3% (5) 6.3% (5) 1.00
Reinfarction 4.3% (4) 2.4% (4) 0.37 5.1% (4) 2.5% (2) 0.41
Heart failure 3.2% (3) 1.7% (3) 0.29 3.8% (3) 1.3% (1) 0.31
TLR 9.8%(9) 2.9% (5) 0.19 11.4% (9) 1.3% (1) 0.01
TVR 9.8%(9) 2.9% (5) 0.19 11.4% (9) 1.3% (1) 0.01
Stent thrombosis 2.2% (2) 0.6% (1)
0.25
2.4% (2) 1.3% (1)
Acute 1.1% (1) 0.0% (0) 1.3% (1) 0.0% (0) 0.56
Subacute 1.1% (1) 0.6% (1) 1.3% (1) 1.3% (1)
Peak troponin I (ng/dL) 90.16 ± 82.11 115.53 ± 128.88 0.44 91.32 ± 86.08 95.75 ± 105.20 0.68

9. 9
CONCLUSION
Our study is the first to compare the MGS with the BMS in
STEMI in the real world.
MGS is a safe device in STEMI that is not associated with
increased mortality.
MGS has a higher long-term TLR rate compared with BMS